Webinar June 15, 2020
U.S. FDA Latin America Office, IMDRF: WGs and Priorities, MD Division (CDRH) & LatAm Activities, FDA Standards & Conformity Program/Policy and MDSAP & ISO13485. Agenda, Slides Deck, FDA Presentation – Talking Points, Webinar Recording U.S. Food and Drug Administration The Center for Devices and Radiological Health (CDRH) – FDA provides a web page for multimedia industry education. The…
The United States Agency for International Development (USAID), the National Planning Department (DNP), the Ministry of Health and Social Protection (MinSalud), the Ministry of Commerce, Industry and Tourism (MinCIT), the National Institute of Vigilance od Medicines and Food (INVIMA) through the Directorate of Medical Devices and Other Technologies, the Medical Devices and Health Supplies Chamber…
The United States Agency for International Development (USAID), the National Planning Department (DNP), the Ministry of Health and Social Protection (MinSalud), the Ministry of Commerce, Industry and Tourism (MinCIT), the National Institute of Vigilance od Medicines and Food (INVIMA) through the Directorate of Medical Devices and Other Technologies, the Medical Devices and Health Supplies Chamber…
Office of the United States Trade Representative
This virtual series spotlight how countries in the Western Hemisphere are applying Good Regulatory Practices (GRPs) and provide an opportunity for trade and regulatory officials from the region to exchange information about ongoing GRP-related initiatives and ideas for the future. Presentations can be accessed through the following links in the original languages:
World Trade Organization
Objective: The webinar focused on regulatory cooperation and its role in facilitating access to medical technologies, especially in the context of COVID-19. While technical regulations, standards and conformity assessment procedures for health-related products are vital for ensuring safety, efficacy and quality, differences between countries could prevent businesses from engaging in trade and supplying their products to patients…
WHO Relevant Recent Publications on Good Regulatory Practices, Good Reliance Practices and Post-market Surveillance were introduced by the leaders responsible for their development at the WHO, with the purpose to get the Coalition’s members becoming familiar with them and promote a wider utilization. Presentation on Good regulatory practices for regulatory oversight of medical products and…
On March 16th and 17th the InterAmerican Coalition for Regulatory Convergence – Medical Technology Sector (IACRC) hosted the Workshop on Good Regulatory Practices (GRP) and International Trade for the Brazilian stakeholders. The workshop was co-hosted and supported by ABIMED, ABIIS, ABRAIDI and CBDL, and joined by several authorities, representatives from academia and the private sector.…
COVID-19, Impact, response, recovery; Lessons learned from COVID-19 & The Role of the WTO TBT Agreement & GRPs in support of Medical Device Regulatory Convergence were address by experts at the London School of Hygiene and Tropical Medicine, FDA — LATAM Office, WHO, PAHO, CBDL/ALADDIV, Ministry of Economy of Brazil and The Office of the U.S.…
Good Regulatory Practices in Mexico from the perspective of the Executive (CONAMER, DGN, COFEPRIS), Legislative (Chamber of Deputies) and Judicial (Superior Court of Administrative Justice) Powers, including obligations stated at multilateral agreements (TBT, OECD and USMCA). Materials available in Spanish only. Agenda Slides Deck Recording The Coalition held a series of educational webinars to provide…
Session 1 – May 26, 2020 Regulatory Convergence and International Benchmarks: WHO, IMDRF, MDSAP. Session 2 – June 2, 2020 Global Perspectives: GMTA, MDUFA, 21st Century Cures, APEC MD Initiative, GRPs and International Benchmarks: OECD, IDB, ABD, APEC & Advancing Opportunities from the COVID-19 Pandemic. Session 3 – June 9, 2020 World Trade Organization and…
